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  5. NDC Package Code: 58160-909-52 Fluarix Quadrivalent 2023/2024

NDC Package 58160-909-52 Fluarix Quadrivalent 2023/2024

Influenza Virus Vaccine Suspension Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58160-909-52
Package Description:
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-909-41)
Product Code:
58160-909
Proprietary Name:
Fluarix Quadrivalent 2023/2024
Non-Proprietary Name:
Influenza Virus Vaccine
Substance Name:
Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)
Usage Information:
FLUARIX QUADRIVALENT is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see Description (11)]. FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.
11-Digit NDC Billing Format:
58160090952
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2641626 - influenza virus vaccine 2023-2024 (quadrivalent - Darwin/6/Victoria/Austria/Phuket) 0.5 ML Prefilled Syringe
  • RxCUI: 2641626 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe
  • RxCUI: 2642300 - FLUARIX QUADRIVALENT 2023-2024 vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2642300 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe [Fluarix Quadrivalent 2023-2024]
  • RxCUI: 2642300 - Fluarix Quadrivalent 2023-2024 vaccine 0.5 ML Prefilled Syringe
    • Product Type:
    Vaccine
    Labeler Name:
    Glaxosmithkline Biologicals Sa
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125127
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-30-2023
    End Marketing Date:
    06-30-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58160-909-52?

    The NDC Packaged Code 58160-909-52 is assigned to a package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-909-41) of Fluarix Quadrivalent 2023/2024, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is suspension and is administered via intramuscular form.

    Is NDC 58160-909 included in the NDC Directory?

    Yes, Fluarix Quadrivalent 2023/2024 with product code 58160-909 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on June 30, 2023.

    What is the NDC billing unit for package 58160-909-52?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 58160-909-52?

    The 11-digit format is 58160090952. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-258160-909-525-4-258160-0909-52